A mus­cled up Mod­er­na fi­nal­ly joins the CO­V­AX crew, pledg­ing 500M dos­es for low-in­come coun­tries

Days af­ter tur­bocharg­ing its Covid-19 vac­cine man­u­fac­tur­ing ca­pac­i­ty to the tune of 3 bil­lion dos­es per year, Mod­er­na an­nounced Mon­day it has struck a deal with Gavi, the vac­cine al­liance, to sup­ply up to 500 mil­lion dos­es of its shot to the low­est in­come coun­tries by the end of next year.

The dis­cus­sions date back at least to last Oc­to­ber, when Mod­er­na told in­vestors about on­go­ing dis­cus­sions with CO­V­AX “on a tiered pric­ing pro­pos­al for pur­chas­ing mR­NA-1273.”

All dos­es will be sold at the “low­est tiered price,” ac­cord­ing to the Cam­bridge, MA-based biotech, and be dis­trib­uted among 92 coun­tries.

Un­der the fi­nal agree­ment, Mod­er­na will be­gin de­liv­ery of 34 mil­lion dos­es in Q4 of 2021, while the CO­V­AX fa­cil­i­ty — spear­head­ed by Gavi, WHO and CEPI — has an op­tion to pro­cure the re­main­ing 466 mil­lion dos­es fol­low­ing those ini­tial ship­ments.

CEPI, the Nor­way-based group ded­i­cat­ed to fund­ing epi­dem­ic pre­pared­ness, had giv­en Mod­er­na a $900,000 grant back in Jan­u­ary 2020. The WHO, mean­while, had just added mR­NA-1273 — which was shown to be about 95% ef­fec­tive in Phase III tri­als and con­tin­ues to of­fer de­cent pro­tec­tion against vari­ants in re­al world set­tings — to the list of vac­cines it rec­om­mends for emer­gency use against Covid-19.

With shots from Pfiz­er, As­traZeneca and the Serum In­sti­tute of In­dia in its port­fo­lio, CO­V­AX has so far shipped over 49 mil­lion Covid-19 vac­cines. The largest donor, though, is No­vavax, which has agreed to sup­ply 1.1 bil­lion dos­es of its yet-to-be-ap­proved pro­tein-based jab.

“Ex­pand­ing and hav­ing a di­verse port­fo­lio has al­ways been a core goal for CO­V­AX, and to re­main adapt­able in the face of this con­tin­u­al­ly evolv­ing pan­dem­ic – in­clud­ing the ris­ing threat posed by new vari­ants,” Gavi chief Seth Berkley said in a state­ment.

In a re­cent in­ter­view with End­points News, Mod­er­na CEO Stéphane Ban­cel de­scribed their ex­pand­ed pro­duc­tion com­mit­ment as a “mas­sive in­vest­ment” aimed at vac­ci­nat­ing and boost­ing pop­u­la­tions around the world.

“We said look, we have a cer­tain re­spon­si­bil­i­ty as a com­pa­ny and we will in­vest ag­gres­sive­ly … so that next year we can have a big im­pact,” Ban­cel said. “If you think about it, look at the pop­u­la­tion of the plan­et, you see that 70% of peo­ple want the vac­cine, which is what we’re see­ing in polls across the world, and if we can make 3 bil­lion vac­cines, that will be, for a com­pa­ny that just launched its first prod­uct a few months ago, ex­tra­or­di­nary.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Hedge fund jumps in with Avoro ac­tivists in an at­tempt to de­rail Mer­ck­'s $11B Ac­celeron buy­out

Avoro Capital, which made its bones blowing up the Seagen-Immunomedics deal and then selling the smaller biotech for $21 billion, is getting an assist in its quest to derail Merck’s $11 billion buyout of Acceleron $XLRN.

Wednesday morning one of Acceleron’s biggest investors joined the opposition. Darwin Global Management, a hedge fund which owns about 4% of Acceleron, blasted the Merck deal, saying the Big Pharma is getting the company for billions less than what it’s worth. Earlier, Holocene Advisers, reportedly a top-20 investor in Acceleron, said it would not tender its stock after criticizing the $180-per-share deal.

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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.